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Completed

NCT Number: NCT04142580

Correlation Between RMI of Degenerative Disk Disease and Reduction of Pain After Disk-infiltration Treatments

The primary objective of the study is to demonstrate the difference in the reduction of pain at 1 month after intradiscal infiltration of corticosteroids depending on symmetrical or asymmetrical active discopathies with MRI examination. The difference should be judged significant if it ⩾ 2 points.

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Key information

Conditions

Discopathy Back Pain Low Back Pain Lumbago Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'imagerie médicale, Hôpital Raymond Poincaré, Garches, France

Garche, 92380, France

About this study

As secondary objective, the study aims to study the correlation between pain reduction which will be assessed by numerical scale at 1 month and 6 months after intradiscal infiltration of corticosteroids and following parameters: the duration of chronic lumbago, the presence of associated root pains, the morphological characteristics with RMI examination of active discopathies, the co-existence of scoliosis, the sign of inter-somatic instability, the muscular trophicity of muscle erector of low back, the pelvic incidence, degree of lumbar lordosis, Cobb angle, wearing a corset.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ⩾ 18 years.
  • Chronic growing lumbago with duration > 3 mois.
  • Disabling lumbago with an average ⩾ 4/10 defined by numerical scale.
  • Common chronic low back pain that has been evolving for more than 3 months.
  • Disabling lumbalgia defined by an average numerical scale greater than or equal to 4/10 in the month preceding the inclusion.
  • Failure or intolerance to drug treatments (nonsteroidal anti-inflammatory drugs and systemic corticosteroids).
  • Absence of biological inflammatory syndrome.
  • Recent MRI of less than 6 months with active disc disease (Modic 1) defined by degenerative disc disease associated with mirror rearrangements of the subchondral bone of the adjacent vertebral endplates in hyposignal T1 and hypersignal T2.
  • Signed informed consent obtained.
  • Affiliation to social security.

Exclusion criteria

  • Pregnancy woman.
  • Immunosuppression.
  • History of allergy to iodinated contrast agents and / or prednisolone acetate.
  • Local or general infection.
  • Fever (temperature> 38).
  • History of disc surgery of less than 6 months.
  • History of infectious spondylodiscitis.
  • Unbalanced psychiatric disorders.
  • Severe coagulation disorders or impossible cessation of anticoagulation or anti platelet aggregation.
  • Impossibility to obtain signed consent form.
  • Patient under guardianship and/or curatorship.

Treatment and study plan

Primary outcomes

  1. Assessement of change in pain

    Time frame: at 1 month

    The change in pain will be evaluated by numerical scale NRS (numeric rating scale) by phone call after intradiscal infiltration of corticosteroids.

    NRS for pain: a scale from 0 (no pain) to 10 (worst pain). RMI examination will be performed 6 months before enrollment.

Secondary outcomes

  1. Assessement of pain reduction according to the duration of evolution of chronic lumbago

    Time frame: at 1 month and 6 months

    The change in pain will be evaluated by NRS for pain (numeric rating scale for pain, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the duration of evolution of chronic lumbago or not will be assessed. Duration of pain before infiltration will be evaluated in months during the pre-inclusion consultation.

  2. Assessement of pain reduction according to the presence of associated root pains or not.

    Time frame: at 1 month and 6 months

    The presence of associated root pains will be evaluated by NRS for pain (numerical rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of associated root pains or not will be assessed. Patients will be asked if there is any root pain during the pre-inclusion consultation.

  3. Assessement of pain reduction according to the co-existence of scoliosis or not.

    Time frame: at 1 month and 6 months

    The pain reduction and the co-existence of scoliosis will be assessed. The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of associated scoliosis or not will be assessed. Scoliosis will be investigated by interviewing the patient and analyzing the patient's x-rays, performed as part of routine care prior to the pre-inclusion consultation. Scoliosis is any lateral spinal curvature with a Cobb angle >10° on x-rays.

  4. Assessement of pain reduction according to the presence of signs of inter-somatic instability

    Time frame: at 1 month and 6 months

    The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of signs of inter-somatic instability or not will be assessed. Signs of inter-somatic instability will be investigated by interviewing the patient and analyzing the patient's x-rays and MRI, performed as part of routine care prior to the pre-inclusion consultation. Intersomatic instability is defined as the anterior, posterior or lateral translational displacement of a vertebral body against another (more than 3 mm) on x-rays or MRI.

  5. Assessement of pain reduction according to the presence of posterior articular osteoarthritis

    Time frame: at 1 month and 6 months

    The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of posterior articular osteoarthritis or not will be assessed. Signs of posterior articular osteoarthritis will be investigated by interviewing the patient and analyzing the patient's x-rays and MRI, performed as part of routine care prior to the pre-inclusion consultation. Posterior articular osteoarthritis will be defined by the presence of bone protrusions, narrowing of joint space, effusion of the joint and periarticular inflammation on x-rays or MRI.

  6. Assessement of pain reduction according to the muscle trophicity of the erector muscles of the lumbar spine

    Time frame: at 1 month and 6 months

    The change in pain will be evaluated by NRS for pain (numeric rating scale, a scale from 0 to 10) by phone call after intradiscal infiltration of corticosteroids, according to the presence of an atrophy of the erector muscles of the lumbar spine or not will be assessed. Signs of atrophy of the erector muscles of the lumbar spine will be investigated by interviewing the patient and analyzing the patient's MRI, performed as part of routine care prior to the pre-inclusion consultation. Atrophy of the erector muscles of the lumbar spine will be defined by the presence fat infiltration in erector muscles of the lumbar spine MRI.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evolution of Chronic Low Back Pain of Active Discopathy After Intradiscal Corticosteroid Infiltrations According to Modic 1 Distribution and Association With Degenerative Restructuring

Acronym: MODISC

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 29, 2019
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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